Amgen today announced data from the ultimate evaluation of the Phase 2 OCEAN(a)-DOSE study of olpasiran, a small interfering RNA (siRNA) through the Late-Breaking Science Session on the European Society of Cardiology (ESC) Annual Meeting being held in Amsterdam. Within the off-treatment extension period, olpasiran showed a long-lasting effect on Lp(a) reduction nearly a 12 months after the last dose.

Results from the OCEAN(a)-DOSE Phase 2 study announced in November of 2022 showed that doses of olpasiran ≥75 mg Q12W reduced patients’ Lp(a) by >95% at week 36. The outcomes from the off-treatment extension period show that patients previously dosed with ≥75 mg of olpasiran sustained a ~40-50% placebo-adjusted percent reduction in Lp(a) nearly a 12 months after the last dose. No recent safety concerns were identified through the off-treatment extension period.

We’re dedicated to reducing LDL levels of cholesterol in people globally and continuing to pioneer ways to deal with the best risk aspects in heart problems, including Lp(a). Worldwide, hundreds of thousands of persons are at an increased risk of cardiovascular events attributable to elevated Lp(a) levels. Unfortunately, there are not any approved medicines. Data from the off-treatment extension period provide additional evidence of olpasiran’s lasting effect in reducing Lp(a) levels. We’re quickly advancing the Phase 3 cardiovascular consequence trial.”

Paul Burton, Senior Vice President and Chief Medical Officer, Amgen

Moreover, this study was the primary to explore the results of olpasiran on a key biomarker strongly related to atherosclerosis, pro-atherogenic OxPL-apoB [Oxidized Phospholipids (Ox-PL) on apoB-100 (apoB)]. Throughout the treatment period, olpasiran showed a dose-dependent reduction in pro-atherogenic OxPL-apoB.

“Additional results from the OCEAN(a)-DOSE study proceed to be encouraging, as they tell us olpasiran not only robustly reduces Lp(a) levels, but that it has a long-lasting effect on this necessary risk factor for ASCVD,” said Michelle L. O’Donoghue, MD, MPH, associate professor, Harvard Medical School, Cardiovascular Medicine and lead investigator of the OCEAN(a)-DOSE study. “Moreover, we were in a position to show that olpasiran reduced OxPL-apoB, further adding to the potential of RNA interference with olpasiran as a promising treatment approach to reducing elevated Lp(a).”

LDL awareness to motion implementation consortium

Amgen is committed to working with stakeholders to attain the goal of reducing heart problems globally and, this 12 months at ESC, convened a recent LDL Awareness to Motion Implementation Consortium (LATAIC). LATAIC is targeted on improving LDL-C testing and evidence-based treatment through identification of opportunities to speed up efficiency and impact of the interpretation of evidence-based research into clinical practice. The consortium is comprised of leading CV institutions, including Duke, Harvard’s BAIM Institute, Johns Hopkins, Geisinger, University of Colorado, St. Luke’s, Brigham and Women’s Hospital, Windfall, Yale and UT Southwestern.

“I’m proud to be working alongside Amgen and other cross disciplinary leaders within the cardiovascular space to extend LDL-C testing and implementation of evidence-based treatment, with a view to tackle the urgent public health crisis of heart problems,” said C. Michael Gibson, M.D., chief executive officer on the non-profit BAIM Institute of Clinical Research, and professor of drugs, Harvard. “We hope to enable scalable motion to deal with unmet LDL needs, drive efficiency, and improve quality of look after patients by expanding LATAIC to incorporate other CVD industry stakeholders.”